ABSTRACT
Background:The aim of this study was to compare the efficacy of ozone injection at Tibio-femoral joint with Supra-patellar recess on knee osteoarthritis (OA).Methods: In this randomized, controlled clinical trial, 99 patients with symptomatic knee OA were randomized into two groups. 47 patients selected to receive 7-8 ml ozone (20 μg/ml) through Tibio-femoral joint injection, and 49 patients received 10 ml ozone (20μg/ml) through supra-patellar recess injection by using in-plane ultrasound-guided. The primary outcome was the change from baseline in the visual analogue scale (VAS)(0-100 mm) pain score during 3 months after injection. Secondary outcome measures included the Western Ontario and McMaster universities OA Index (WOMAC), Lequesne index, time “Up and Go” (TUG) test, single-limb stance (SLS) tests, patient satisfaction, and adverse effects. All of these measurements were evaluated at the base time, 48 hours, 2 weeks, 1 month, 2 months, and 3 months after injection.Results:Both groups had significantly improvement in the primary and secondary outcome measures. VAS pain score except at the 3–month follow-up (16.8±13.3 versus 18.1±16.6, 95% CI, -7.33 to 4.73, p =0.6), WOMAC pain score, WOMAC stiffness score at all evaluated times, and WOMAC total score at 48 hours after injection (95% CI, -19.4 to -4.9) were significantly better among Tibio-femoral ozone injection compare to Supra-patellar recess injection (95% CI, -20.68 to -6.51,p<0.001)). In both groups satisfaction, TUG and SLS times were improved, but no significant difference was seen between groups (p>0.05). At the 3-month follow-up, WOMAC pain and total scores for only Tibio-femoral joint injection group as well as WOMAC function, TUG and SLS times for both groups were gradually coming back to the baseline.Conclusion:Ozone injection in both groups was associated withpain relief, functional improvement, and quality of life in patient with knee OA. Pain and stiffness of joint were improved better in Supra-patellar recess ozone injection